SchizophreniaNCT06732817
Personalized Dual-target RTMS for Patients with Refractory Schizophrenia
A study testing Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging (fMRI)
- What is being tested?
- Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed by independent psychiatrists using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition;
- disease duration longer than six years;
- hospitalization two or more times;
- aged 18-60 years;
- a stable dosage of antipsychotic medication for at least four weeks before inclusion, and retention of this stable dose for the duration of the study.
Who cannot join
- accompanied by other mental illnesses or histories;
- pregnant;
- a history of severe head trauma or neurological disease;
- focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery MRI;
- a history of rTMS or electroconvulsive therapy in the six months prior to the study; and
- metal objects in the head or any other contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Repetitive Transcranial Magnetic Stimulation for Patients with Refractory Schizophrenia: an Open-label Study
The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI.
The main questions it seeks to address are:
Read more
Does the dual-target rTMS protocol improve clinical symptoms in patients with refractory schizophrenia? What neural circuit changes, as assessed by functional MRI, occur following rTMS treatment?
Participants will:
Undergo personalized, dual-target rTMS treatment daily for 3 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).
Have structural and resting-state functional MRI scans before and after treatment.
Be monitored for any treatment-related adverse events.
Read the detailed description
This open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rTMS protocol for treating patients with refractory schizophrenia. Patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rTMS treatment.
Before treatment, structural and resting-state functional MRI data were collected from each patient. Clinical symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) was also administered. Additionally, a battery of neuropsychological tests was conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).
After completing the 3-week rTMS treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional MRI data were reassessed.
- Conditions
- Schizophrenia, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging (fMRI)
- Being tested
- Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).
- Keywords
- schizophrenia, transcranial magnetic stimulation, dual-target
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).Device
Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks (21 consecutive days), using a transcranial magnetic stimulator (Rapid2; MagStim) with a 70-mm air-cooled figure-of-eight coil. Stimulation at 20 Hz (2 seconds on, 28 seconds off) was applied over the left DLPFC with an intensity set at 100% of the individual resting motor threshold (RMT), delivering a total of 1,600 pulses daily. Continuous theta burst stimulation (cTBS) was applied over the left TPJ at either 100% of the individual RMT or at the highest intensity that the stimulator could deliver for this protocol (50% of maximum output). Three daily sessions of cTBS were administered, separated by two 15-minute breaks, delivering a total of 1,800 pulses daily. The coil was navigated in real-time using a frameless neuro-navigation system (Brainsight; Rogue Research, Montreal, Quebec, Canada).
| Study group | Role | What they receive |
|---|---|---|
| Personalized dual-target active rTMS treatment | Active comparator | Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks. Receives: Device: Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive And Negative Syndrome Scale (PANSS)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 3. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
Measured: baseline and week 3 (post-treatment)
Secondary outcomes (4)
Positive and Negative Syndrome Scale (PANSS) subscales
Secondary outcomes included changes in the PANSS subscales score. PANSS positive score and negative score range 7 to 49, the higher scores indicate more severe symptoms. PANSS general score range 16 to 112, the higher scores indicate more severe symptoms.
Measured: baseline and week 3 (post-treatment)
Hamilton Anxiety Rating Scale (HAMA)
Secondary outcomes included changes in the HAMA score. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety
Measured: baseline and week 3 (post-treatment)
Hamilton Depression Rating Scale (HAMD)
Secondary outcomes included changes in the HAMD score. HAMA scale scores range from 0 to 50 points, the higher the score indicates the more serious depression.
Measured: baseline and week 3 (post-treatment)
Auditory Hallucination Rating Scale (AHRS)
The changes in the Auditory Hallucination Rating Scale (AHRS) score were also included as a secondary outcome. AHRS range 0 to 41, the higher scores indicate more severe symptoms.
Measured: baseline and week 3 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Apr 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732817
- Sponsor's protocol ID
- AHMU-TMS-SCZ
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Repetitive Transcranial Magnetic Stimulation for Patients with Refractory Schizophrenia: an Open-label Study
- ClinicalTrials.gov ID
- NCT06732817
- Acronym / sponsor ID
- AHMU-TMS-SCZ
- Conditions
- Schizophrenia, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- schizophrenia, transcranial magnetic stimulation, dual-target
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI.
The main questions it seeks to address are:
Does the dual-target rTMS protocol improve clinical symptoms in patients with refractory schizophrenia? What neural circuit changes, as assessed by functional MRI, occur following rTMS treatment?
Participants will:
Undergo personalized, dual-target rTMS treatment daily for 3 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).
Have structural and resting-state functional MRI scans before and after treatment.
Be monitored for any treatment-related adverse events.
Detailed description
This open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rTMS protocol for treating patients with refractory schizophrenia. Patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rTMS treatment.
Before treatment, structural and resting-state functional MRI data were collected from each patient. Clinical symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) was also administered. Additionally, a battery of neuropsychological tests was conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).
After completing the 3-week rTMS treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional MRI data were reassessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized dual-target active rTMS treatment | Active comparator | Device: Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosed by independent psychiatrists using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition;
- disease duration longer than six years;
- hospitalization two or more times;
- aged 18-60 years;
- a stable dosage of antipsychotic medication for at least four weeks before inclusion, and retention of this stable dose for the duration of the study.
Key exclusion criteria (6 listed)
- accompanied by other mental illnesses or histories;
- pregnant;
- a history of severe head trauma or neurological disease;
- focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery MRI;
- a history of rTMS or electroconvulsive therapy in the six months prior to the study; and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks (21 consecutive days), using a transcranial magnetic stimulator (Rapid2; MagStim) with a 70-mm air-cooled figure-of-eight coil. Stimulation at 20 Hz (2 seconds on, 28 seconds off) was applied over the left DLPFC with an intensity set at 100% of the individual resting motor threshold (RMT), delivering a total of 1,600 pulses daily. Continuous theta burst stimulation (cTBS) was applied over the left TPJ at either 100% of the individual RMT or at the highest intensity that the stimulator could deliver for this protocol (50% of maximum output). Three daily sessions of cTBS were administered, separated by two 15-minute breaks, delivering a total of 1,800 pulses daily. The coil was navigated in real-time using a frameless neuro-navigation system (Brainsight; Rogue Research, Montreal, Quebec, Canada). | Device | Personalized dual-target active rTMS treatment |
Primary outcome
Positive And Negative Syndrome Scale (PANSS)
Time frame: baseline and week 3 (post-treatment)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 3. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
4 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) subscales
Time frame: baseline and week 3 (post-treatment)
Hamilton Anxiety Rating Scale (HAMA)
Time frame: baseline and week 3 (post-treatment)
Hamilton Depression Rating Scale (HAMD)
Time frame: baseline and week 3 (post-treatment)
Auditory Hallucination Rating Scale (AHRS)
Time frame: baseline and week 3 (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive And Negative Syndrome Scale (PANSS) (time frame: baseline and week 3 (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.